MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN MONO/POLYAXIAL SCREWS; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients all information is provided in the article.This report is for an unknown mono/polyaxial screws/unknown lot.Part and lot number are unknown; udi number is unknown.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

This report is being filed after the review of the following journal article: decker, s., herden, j., krettek, c., and müller, c.W.(2006), a new minimally invasive u-shaped lumbopelvic stabilization technique, european journal of orthopaedic surgery & traumatology, vol.29 (6), pages 1223¿1230 (germany).The aim of this retrospective cohort study is to present a percutaneous minimally invasive technique for lps as well as our first clinical results.A total of 10 patients (3 male and 7 female) aged = (b)(6) years underwent lumbopelvic stabilization (lps).Surgery was performed using viper ii and expedium instrumentation (johnson and johnson, usa).Follow-up period was unknown.The following complications were reported as follows: a (b)(6) year old female patient underwent correction of loosened screw cap.A (b)(6) year old female patient underwent revision of screw loosening with loss of reduction, augmentation.A (b)(6) year old female patient required correction of initially misplaced iliac screw during surgery then underwent implant removal because of implant prominence.A (b)(6) year old female patient underwent implant removal to release healthy disks.This report is for an unknown depuy spine mono/polyaxial screws and unknown depuy spine screw/rod construct (viper 2 and expedium).This report is for one unknown mono/polyaxial screws.This is report 5 of 10 for (b)(4).

• Brand Name: UNKNOWN MONO/POLYAXIAL SCREWS
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 9532199
• MDR Text Key: 189225550
• Report Number: 1526439-2019-52839
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2019
• Initial Date FDA Received: 12/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention